The Union Ministry of Health and Family Welfare has announced comprehensive regulatory reforms in the medical device sector aimed at easing licensing requirements and speeding up market access. According to the Press Information Bureau (PIB), the government has proposed key amendments to the Medical Devices Rules, 2017, including Rule 44 governing outsourced sterilisation activities. Under the amended provisions, medical device manufacturers that outsource product sterilisation to another facility holding a valid licence under the Medical Devices Rules, 2017, will no longer be required to obtain a separate loan licence for the outsourced sterilisation activity. The government has provided a six-month transition period to implement the new labelling requirement, allowing companies to make necessary changes to their labelling, packaging and related processes before the provision comes into effect.
The Ministry of Health and Family Welfare has mandated that medical device manufacturers outsourcing sterilisation must disclose the licence number of the subcontractor on device labels. According to reports from Business Standard, this requirement was introduced through a gazette notification amending the Medical Devices Rules, 2017, which modified Rule 44 governing mandatory labelling requirements for medical devices. The notification states that in cases where manufacturers outsource sterilisation activities to facilities with valid licences, the sterilisation site's licence number must be mentioned on the device label. The revised framework seeks to balance regulatory oversight with ease of doing business by simplifying the licensing process while retaining an essential traceability mechanism for outsourced sterilisation.
Domestic medical device manufacturers have raised significant concerns over the new compliance requirement. As reported by Business Standard, Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), stated that the requirement could be particularly troublesome for export shipments because it would limit manufacturers' ability to shift production between approved sterilisation providers, depending on turnaround time and available capacity. However, the latest reforms address these concerns by removing the separate loan licensing requirement, which will reduce duplication, administrative burden, compliance costs and associated timelines, particularly for manufacturers that do not have in-house sterilisation facilities. The measures are expected to provide greater operational flexibility and support the growth and competitiveness of India's medical device industry.
The Association of Indian Medical Device Industry (AiMeD) has raised concerns about the rule's potential impact on global competitiveness. According to reports from Business Standard, AiMeD claimed that no other jurisdiction requires subcontractor details to be printed on packaging, and the rule could make Indian medical device manufacturers less globally competitive. The organisation noted that globally, regulations place the onus of quality and traceability on manufacturers, whose documentation provides batch-level accountability. The latest reforms are expected to reduce regulatory burden and associated timelines for importers and manufacturers, while strengthening international regulatory convergence in the medical device sector.
In a separate development, the government has proposed amending Rule 63 of the Medical Devices Rules, 2017 to include the European Union among the recognised stringent regulatory jurisdictions for waiver of clinical investigation requirements for medical devices without predicate devices. The provision currently recognises the United States, United Kingdom, Australia, Canada and Japan, according to the Press Information Bureau (PIB). The EU's inclusion will allow qualified medical devices that have previously received EU approval to take advantage of the waiver provisions, which might speed up patient access to cutting-edge medical advances in India. This amendment is expected to reduce regulatory burden and associated timelines for importers and manufacturers, while strengthening international regulatory convergence in the medical device sector.
